Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 16
- 主要终点
- Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
研究概览
简要总结
This multi-site randomized controlled trial compares the effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) as developed by Cohen, Mannarino & Deblinger (2006) with a wait-list condition in a population of children aged 7-16 years who were exposed to traumatic events beyond the age of three years, at least three months ago, and developed Posttraumatic Stress Disorder (PTSD). Primary aims are to provide evidence that TF-CBT exceeds spontaneous remission of posttraumatic stress symptoms and to assess maintenance of treatment gains at 6 and 12 months post-treatment. Secondary aims are to evaluate the effectiveness of TF-CBT in reducing other psychopathology and cognitive distortions of patients and caregivers and to explore moderators and mediators of treatment response. The trial will contribute to implement an evidence-based treatment for traumatized children across a variety of healthcare settings in Germany. The novel aspect is to evaluate the effectiveness of TF-CBT with a broad range of traumatized "real-world" patients in the context of the German mental healthcare system.
详细描述
Complete study protocol (in German) available from the PI lutz.goldbeck@uniklinik-ulm.de
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 7-16 years
- •Exposure to a traumatic event (index trauma) after the age of 3 years, at least 3 months before assessment
- •≥35 points on the Clinician -Administered PTSD Scale for Children and Adolescents (CAPS-CA) total symptom severity score and at least one symptom per PTSD cluster related to the index trauma according to DSM IV diagnostic criteria
- •PTSD should be the main mental health problem, patients with co-morbid mental disorders are included
- •No major brain injury of the child due to the traumatic event (Glasgow Coma Scale <9 points at primary medical examination)
- •Co-operation of at least one non-offending primary caregiver (improves treatment outcome)
- •Living within reasonable distance (max 1 hour of travel) to the treatment center to allow treatment on a weekly basis (feasibility)
排除标准
- •Psychosis
- •Acute suicidality
- •Psychopharmacological medication started or changed up to 6 weeks before first assessment
结局指标
主要结局
Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)
时间窗: Change from Baseline at 16 weeks (=end of treatment)
Symptom severity score
次要结局
- Change from Baseline in Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)(Change from Baseline at 16 weeks (=end of treatment))
- Change from Baseline in UCLA PTSD Reaction Index (self-report and caregiver report)(Change from baseline at 12 months post-treatment)
- Change from Baseline in Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK; Self-report and caregiver report)(Change from Baseline at 12 months post-treatment)
- Change from Baseline in Children's Global Assessment Scale (CGAS)(Change from Baseline at 12 months post-treatment)
- Change from Baseline in State-Trait-Anxiety-Inventory (STAI)(Change from Baseline at 12 months post-treatment)
- Change from Baseline in Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)(Change from baseline at 12 months post-treatment)
- Change from Baseline in Self-report for childhood anxiety related disorders (SCARED; Self-report and caregiver report)(Change from Baseline at 12 months post-treatment)
- Change from Baseline in Child Behavior Checklist (CBCL 4/18)(Change from Baseline at 12 months post-treatment)
- Change from Baseline in Child Post Traumatic Cognitions Inventory (CPTCI)(Change from Baseline at 12 months post-treatment)
- Change from Baseline in Beck Depression Inventory (BDI-II)(Change from Baseline at 12 months post-treatment)
- Change from Baseline in Children's Depression Inventory (CDI)(Change from Baseline at 12 months post-treatment)
- Change from Baseline in The Posttraumatic Cognitions Inventory (PTCI)(Change from Baseline at 12 months post-treatment)
- Change from Baseline in Posttraumatic Diagnostic Scale (PDS)(Change from Baseline at 12 months post-treatment)
- Change from baselinein Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA)(Change from Baseline at 6 monts post-treatment)
研究者
Lutz Goldbeck
Head of Section for Psychotherapy Re-search and Behavioural Medicine
University of Ulm